Cardiac Troponin I Diagnostic Kit - India CDSCO Medical Device Registration

Cardiac Troponin I Diagnostic Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000034_99321c6f589286720a336f52caa79c22_82413cea07b3e09dec60800838de0947. This device is marketed under the brand name Colloidal Gold. The license holder is APEX DIAGNOSTICS, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Cardiac Troponin I Diagnostic Kit

UID: IMP/IVD/2018/000034_99321c6f589286720a336f52caa79c22_82413cea07b3e09dec60800838de0947

Brand Name

Colloidal Gold

License Holder

APEX DIAGNOSTICS

Device Class

Class C

Approving Authority

CDSCO

Product Information

The cTnI Rapid Test (Colloidal Gold) is a rapid visual immunoassay for the qualitative detection of cardiac Troponin I in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of myocardial infarction (Colloidal Gold)